Perennial Allergic RhinitisPhase 3NCT01900054
A Long-Term Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis
A Phase 3 study testing Bepotastine besilate in people with Perennial Allergic Rhinitis, run by Tanabe Pharma Corporation at 1 site in Japan.
Trial summary
The objective of this study is to evaluate the long-term safety and efficacy of TAU-284 (Bepotastine besilate) in pediatric patients with perennial allergic rhinitis for 12 weeks administration. Read more about this study
- Who is it for?
- Ages 7 to 15 years
- Conditions the study is for
- Perennial Allergic Rhinitis
- What is being tested?
- Bepotastine besilate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteJapan
- Study dates
- Jun 2013to Nov 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients aged between 7 and 15 years
- Patients who have received a diagnosis of perennial allergic rhinitis according to the diagnostic criteria
- Patients with a mean total score for the three major nasal symptoms [sneezing, rhinorrhea, and nasal congestion] of at least 3 on the basis of symptoms recorded in the nasal allergy diary during the observation period etc.
Who cannot join
- Patients with vasomotor rhinitis or eosinophilic rhinitis
- Patients who have concurrent nasal disease that may affect the efficacy of TAU-284
- Patients with a history of any of the nasal surgical procedures
- Patients with current or previous history of drug allergy
- Patients who concurrently have renal function abnormalities that may cause safety problems etc.
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to evaluate the long-term safety and efficacy of TAU-284 (Bepotastine besilate) in pediatric patients with perennial allergic rhinitis for 12 weeks administration.
Read the detailed description
This is a multicenter,open-label, single-arm, uncontrolled study to evaluate the safety and efficacy of TAU-284 (20 mg/day) in pediatric patients with perennial allergic rhinitis for 12 weeks administration.
- Conditions
- Perennial Allergic Rhinitis
- Being tested
- Bepotastine besilate
- Keywords
- TAU-284, Bepotastine besilate, Histamine H1 receptor antagonists, children
- Medical subject headings
- Rhinitis, Allergic, Perennial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bepotastine besilateDrug
Also called TALION 5mg tablets
Two TAU-284 5mg tablets will be taken orally twice a day
| Study group | Role | What they receive |
|---|---|---|
| TAU-284 | Experimental | Two TAU-284 5mg tablets will be taken orally twice a day, once after breakfast and once after dinner (or before bed). Receives: Drug: Bepotastine besilate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Adverse Events and Adverse Drug Reactions
Measured: Up to Week 12
Secondary outcomes (6)
Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] at Week2, Week4, Week6, Week8, Week10, Week 12 and Final Evaluation Point.
Total score for the three major nasal symptoms (sneezing, rhinorrhea, and nasal congestion) were rated on 5-point scale ranging from 0 (no symptom) to 4 (very severe).
Measured: Baseline, Week2, Week4, Week6, Week8, Week10, Week 12 and Final Evaluation Point （up to Week 12）
Change From Baseline in Individual Nasal Symptom Scores (Sneezing, Rhinorrhea, Nasal Congestion, and Impairment in Daily Activities)
Measured: baseline, Week2, Week4, Week6, Week8, Week10 and Week 12
Change From Baseline in Individual Scores for Local Nasal Findings (Rhinoscopic Findings)
Measured: Second enrollment, Week2, Week4, Week6, Week8, Week10 and Week 12
Change From Baseline in Severity Score for Symptoms of Allergic Rhinitis
Measured: baseline, Week2, Week4, Week6, Week8, Week10 and Week 12
Influence of Activities in Daily Life(Study, Outing, Sleeping)
Measured: Second enrollment, Week2, Week4, Week6, Week8, Week10 and Week 12
Patient Impression of Nasal Symptoms(Sneezing, Rhinorrhea, Nasal Congestion, Nasal Pruritus, Eye Pruritus and Eye Tearing)
Measured: Week 12 or suspension
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Perennial Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanabe Pharma Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- KIMIHIRO OKUBO, Study director, Nippon Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01900054
- Sponsor's protocol ID
- TAU-284-18
- Status last verified
- Dec 2025
- First submitted
- 3 Jul 2013
- Last updated
- 7 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Okubo K, Ichimura M, Koyama T, Susuta Y, Izaki H. Double-blind placebo-controlled study of bepotastine besilate in pediatric patients with perennial allergic rhinitis. Expert Opin Pharmacother. 2015;16(16):2395-408. doi: 10.1517/14656566.2015.1085511. Epub 2015 Sep 12.
PubMed 26364765
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-Term Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT01900054
- Acronym / sponsor ID
- TAU-284-18
- Conditions
- Perennial Allergic Rhinitis
- Keywords
- TAU-284, Bepotastine besilate, Histamine H1 receptor antagonists, children
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 16 Jul 2013 (estimated)
- Results
- Posted 14 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the long-term safety and efficacy of TAU-284 (Bepotastine besilate) in pediatric patients with perennial allergic rhinitis for 12 weeks administration.
Detailed description
This is a multicenter,open-label, single-arm, uncontrolled study to evaluate the safety and efficacy of TAU-284 (20 mg/day) in pediatric patients with perennial allergic rhinitis for 12 weeks administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAU-284 | Experimental | Drug: Bepotastine besilateTwo TAU-284 5mg tablets will be taken orally twice a day, once after breakfast and once after dinner (or before bed). |
Who may qualify
- Ages
- 7 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patients aged between 7 and 15 years
- Patients who have received a diagnosis of perennial allergic rhinitis according to the diagnostic criteria
- Patients with a mean total score for the three major nasal symptoms [sneezing, rhinorrhea, and nasal congestion] of at least 3 on the basis of symptoms recorded in the nasal allergy diary during the observation period etc.
Key exclusion criteria (5 listed)
- Patients with vasomotor rhinitis or eosinophilic rhinitis
- Patients who have concurrent nasal disease that may affect the efficacy of TAU-284
- Patients with a history of any of the nasal surgical procedures
- Patients with current or previous history of drug allergy
- Patients who concurrently have renal function abnormalities that may cause safety problems etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bepotastine besilateAlso: TALION 5mg tabletsTwo TAU-284 5mg tablets will be taken orally twice a day | Drug | TAU-284 |
Primary outcome
Number of Patients With Adverse Events and Adverse Drug Reactions
Time frame: Up to Week 12
6 secondary outcomes
Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] at Week2, Week4, Week6, Week8, Week10, Week 12 and Final Evaluation Point.
Time frame: Baseline, Week2, Week4, Week6, Week8, Week10, Week 12 and Final Evaluation Point （up to Week 12）
Change From Baseline in Individual Nasal Symptom Scores (Sneezing, Rhinorrhea, Nasal Congestion, and Impairment in Daily Activities)
Time frame: baseline, Week2, Week4, Week6, Week8, Week10 and Week 12
Change From Baseline in Individual Scores for Local Nasal Findings (Rhinoscopic Findings)
Time frame: Second enrollment, Week2, Week4, Week6, Week8, Week10 and Week 12
Change From Baseline in Severity Score for Symptoms of Allergic Rhinitis
Time frame: baseline, Week2, Week4, Week6, Week8, Week10 and Week 12
Influence of Activities in Daily Life(Study, Outing, Sleeping)
Time frame: Second enrollment, Week2, Week4, Week6, Week8, Week10 and Week 12
Patient Impression of Nasal Symptoms(Sneezing, Rhinorrhea, Nasal Congestion, Nasal Pruritus, Eye Pruritus and Eye Tearing)
Time frame: Week 12 or suspension
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26364765Okubo K, Ichimura M, Koyama T, Susuta Y, Izaki H. Double-blind placebo-controlled study of bepotastine besilate in pediatric patients with perennial allergic rhinitis. Expert Opin Pharmacother. 2015;16(16):2395-408. doi: 10.1517/14656566.2015.1085511. Epub 2015 Sep 12.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
KIMIHIRO OKUBO study director
Nippon Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bepotastine besilate in people with Perennial Allergic Rhinitis, run by Tanabe Pharma Corporation at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With Adverse Events and Adverse Drug Reactions (time frame: Up to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01900054, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.